KMF · Bandage, Liquid
General Hospital · 21 CFR 880.5090 · Class 1
Overview
| Product Code | KMF |
|---|---|
| Device Name | Bandage, Liquid |
| Regulation | 21 CFR 880.5090 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.
Classification Rationale
Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (20 of 222)
Showing 20 most recent of 222 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241916 | TearRepair Liquid Skin Protectant | Optmed, Inc. | Sep 27, 2024 | SESE |
| K182733 | Rochal Bioshield Silicone Film | Rochal Industries, LLC | Jun 27, 2019 | SESE |
| K171148 | Aleo BME Liquid Bandage | Aleo Bme, Inc. | Jan 12, 2018 | SESE |
| K153571 | Cavilon Advanced High Endurance Skin Protectant | 3M Healthcare | Aug 23, 2016 | SESE |
| K160684 | Atteris No-Sting Skin Protectant | Rochal Industries, LLC | Jul 26, 2016 | SESE |
| K131384 | KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE | Kericure, Inc. | Aug 7, 2014 | SESE |
| K133443 | MARATHON NO STING LIQUID SKIN PROTECTANT | Advanced Medical Solutions (Plymouth), Ltd. | Jul 10, 2014 | SESE |
| K120059 | LIQUID BANDAGE | Chesson Laboratory Associates, Inc. | May 17, 2012 | SESE |
| K092712 | SKIN BARRIER FILM | Lodestar Products, Inc. | Feb 23, 2010 | SESE |
| K083087 | ECOCEL | Polichem S.A | Aug 7, 2009 | SESE |
| K083913 | CHESSON LABS LIQUID BANDAGE | Chesson Laboratory Associates, Inc. | Jul 31, 2009 | SESE |
| K083752 | GLUSEAL 90, MODEL GLU9010 | Glustitch, Inc. | Feb 23, 2009 | SESE |
| K082703 | MRDH BANDAGE | Marine Polymer Technologies, Inc. | Oct 14, 2008 | SESE |
| K081009 | NEUTROPHASE | Novabay Pharmaceuticals | May 20, 2008 | SESE |
| K073663 | GELSPRAY WOUND DRESSING | Biocure, Inc. | Jan 30, 2008 | SESE |
| K063202 | PRODERMA LIQUID BANDAGE | Procurement Technology Systems, LLC | May 2, 2007 | SESE |
| K984207 | SILVERLON DIRECT PRESSURE WOUND DRESSING | Argentum International, LLC | Mar 19, 2007 | SESE |
| K062602 | BAND-AID(R) BRAND LIQUID BANDAGE | Johnson & Johnson Consumer Companies, Inc. | Dec 11, 2006 | SESE |
| K053409 | 3M LIQUID BANDAGE | 3M Company | Jun 19, 2006 | SESE |
| K042955 | CUTICOVER SKIN BARRIER DEVICE | D & D Holdings, LLC | Jun 19, 2006 | SESE |
Top Applicants
- Convatec, A Division of E.R. Squibb & Sons — 13 clearances
- Kendall Healthcare Products Co. Div.Of Tyco Health — 9 clearances
- Bioderm, Inc. — 7 clearances
- Smith & Nephew United, Inc. — 7 clearances
- Innovative Technologies , Ltd. — 6 clearances
